in patients with chronic liver diseases(alcoholic liver disease and non-alcoholic fatty liver disease), laennec(human placenta hydrolysate) is to evaluate the efficacy and safety of intravenous drop

Conditions: Chronic Liver Disease

Summary: control group : laennec subcutaneous injection (4 ml) experimental group : laennec intravenous injection (10 ml)

this is a multi- center, randomized, open-label, active-controlled phase 3 trial in participants aged 18 to 70 years with chronic liver disease. it is designed to assess the safety, tolerability and efficacy of both 4 ml sc and 10ml iv laennec when administered twice of week for 6 weeks. a total of 226 participants will be randomised to received 4ml sc or 10ml iv of laennec a 1:1 ratio. and in 4 ml sc and 10 ml iv, the ratio of ald and nafld is 1:3. the investigational product will be administered sc or iv twice of week for a duration of 6 weeks. participants will return to the clinic for follow-up safety and efficacy assessments on weeks 2, 4, 6.

Eligibility criteria:
inclusion criteria: a participant will be eligible for participation in the trial if all of the following inclusion criteria are met: 1. at the time of screening, 19 or 70 years 2. those who have been diagnosed with alcoholic or non-alcoholic fatty liver disease 3. those who have increased alt level (increased alt level : 60 iu/l ≤ alt ≤ 200 iu/l) 4. a person who can complete the signature agreement and comply with clinical trial requirements. exclusion criteria: a participant will not be eligible for trial participation if any of the following exclusion criteria are met: 1. if you have the following disease * liver cancer or other malignant tumor within 5 years at screening point * esophageal varix bleeding, hepatic coma, ascites etc. related disease or child-pugh score class b,c patient within 1 year at screening point * organs or bone marrow transplant experience * billiary atresia, genetic metabolic liver disease, fulminant hepatic failure, toxicity or clinically diagnosed hepatitis, bleeding or platelet disease patient * autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, igg4- associated cholangitis patient * bariatric surgery within 24 weeks at screening point * uncontrolled diabetes mellitus (hba1c \> 9.0%) * uncontrolled serious cardiopulmonary disease * liver cancer or other malignant tumor within 5 years at screening point * those who have alcohol abuse within 5 years at screening point * hepatitis b, c virus (however, those who have been identified as hbv dna undetectable or svr after antiviral administration can participate) * systemic infection (including tuberculosis) 2. if you are taking the following drug (hepatotonics) * however, it is possible to register after having a drug holiday * biphenyl dimethyl dicarboxylate (bdd), silymarin(milk thistle) : 14 days * ursodeoxycholic acid (udca) : 30 days * other hepatotonics : 5 times half-life 3. if you are taking the following drug or need to take drugs during the clinical trial period * antituberculous drug(isoniazid, rifampin etc.), antifungal agent and antibiotic * acetaminophen, nsaids(excluding low-dose aspirin for preventive purposes) * lipid lowering agent(niacin etc.) and oral hypoglycemic agent(acarbose etc.) (registered when administered during the clinical trial period with a certain dose without a change in dose currently being taken) * antiseric agent (arb, beta-blocker, ccb etc.) (registered when administered during the clinical trial period with a certain dose without a change in dose currently being taken) * vitamin e (purpose of treatment of more than 800 iu/day) * astrogens * systemic corticosteroids, immunomodulator 4. if you take more alcohol than the recommended amount (man 40 g/day, woman 20 g/day) 5. drug allergic symptoms (oscillation, heat, itching) 6. those who have received other clinical drugs within 4 weeks before selecting a test subject 7. those who cannot inject intravenous infusions (5% dextrose inj.) 8. a person who does not perform appropriate contraception as a pregnant woman, a nursing or a woman of childbearing age (effective contraception method: barrier methods using infertility surgery, uterine device, condom, killer) 9. those who judged that other testors were inappropriate as clinical trials